Melanoma Clinical Trial

Family Lifestyles, Actions, and Risk Education Intervention: Version 2

Summary

The overall purpose of this study is to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in improving melanoma preventive behaviors. Parent-child dyads, consisting of survivors of melanoma and their children, will be randomly assigned to either receive the FLARE intervention or standard education. Once enrolled, each parent-child dyad will participate in this study for just over 1 year. Both conditions will receive three bi-weekly live intervention sessions (30 minutes per session) with an interventionist, and quarterly boosters via text or email.

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Full Description

Enrollment

After parent-child dyads complete screening and informed consent/assent procedures, participants will be invited to complete an online baseline assessment. Following the baseline assessment, dyads will be randomized to receive either the FLARE intervention or standard education. After randomization, each dyad will receive a unique log-in to a secure study website that will be used to review didactic materials prior to each intervention session.

Intervention Sessions

Dyads will meet with an interventionist via remotely-delivered live session for their three intervention sessions. Intervention sessions will be scheduled every two weeks. After completion of the last remotely-delivered session, all parents will receive quarterly booster messages via text or email.

Study Assessments

Dyads will be asked to complete online assessments after consent is given (baseline) and within the 4 days prior to Session 3. A first post-intervention assessment will occur 4 weeks after the last intervention session is held. A second post-intervention assessment will occur 4 weeks later. The long-term follow-up assessment will take place 1-year post-baseline. Each assessment is expected to take 15-30 minutes. Parents will also receive a brief assessment via text or email (depending on parent preference) at monthly intervals between the second post-assessment and the 1-year post-baseline assessment, and in the summer months immediately following the 1-year post-baseline assessment. All assessments will be completed electronically.

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Eligibility Criteria

Inclusion Criteria:

Adults are eligible for this trial if they:

Are at least 18 years old AND
Have been diagnosed with melanoma at any time in their life AND
Have at least one biological child between the ages of 8-17 years who is able to participate in the trial with them.

Children are eligible to participate with their parent if they:

Are between the ages of 8-17 years AND
Had at least 1 sunburn in the last 12 months AND
Have at least one biological parent with a history of melanoma who can participate in the trial with them.

Exclusion Criteria:

Adults and children will be excluded from participation if they:

Do not speak English OR
Are unable to participate due to developmental delay OR
Received testing for a mutation in CDKN2A/p16, including those who participated in a previous study where they received information on CDKN2A/p16.

Study is for people with:

Melanoma

Estimated Enrollment:

750

Study ID:

NCT04201223

Recruitment Status:

Enrolling by invitation

Sponsor:

University of Utah

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There is 1 Location for this study

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Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

750

Study ID:

NCT04201223

Recruitment Status:

Enrolling by invitation

Sponsor:


University of Utah

How clear is this clinincal trial information?

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